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临床试验/NCT04478916
NCT04478916Unknown不适用

Impact of the Comprehensive Geriatric Assessment on the Quality of Life of Elderly Onco-hematologic Patients' Candidates for Complex Antitumoral Therapies: Clinical and Biological Correlatives

Lorenza Scotti1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2019年12月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
144
试验地点
1
主要终点
Number of patients received planned treatment and CGA evaluated with improvement of good quality of life (QOL)

研究概览

简要总结

Impact of the Comprehensive Geriatric Assessment on the Quality of Life of elderly onco-hematologic patients' candidates for complex antitumoral therapies: clinical and biological correlatives

详细描述

The screenings for the next 2 decades indicate an exponential increase in the incidence of neoplastic diseases in the elderly population. In order to successfully balance effectiveness and low toxicity of immunochemotherapy, a treatment personalisation based on an objective evaluation of fitness is therefore needed. The use of geriatric screening is a first step to rationalize decisions in this regard, the G8 tool has demonstrated the ability to identify patients and mostly to objectively separate elderly fragile patients from those who are fit. In that consideration, the individualization of the anticancer treatment based on a Comprehensive Geriatric Assessment (CGA) is desirable in elderly fragile patients with solid or haematological malignancy. Cancer mortality is constantly increasing after 65 years and the consequent increase in life expectancy favour the processes of cellular senescence. In this context G8 fragility assessment will take place in the screening test and by using the EORTC QLQ-C30C questionnaire to assess quality of life (QoL). The evaluation of senescent cells will be done by real-time PCR. Our aims are i) to evaluate the impact of the CGA on the QoL of elderly onco-haematological patients, candidates for complex therapies, that resulted as fragile at the G8 geriatric screening and ii) to evaluate the senescent cells in the peripheral blood of the patients enrolled in the study. The study is expected to contribute to precision medicine management of elderly patients and refine the therapeutic stratifications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥ 65 years
  • Diagnosis of solid or hematologic cancer
  • Patients who are candidates for a first line therapy for advanced disease to be treated with biological target drugs, or candidates for integrated radiotherapy
  • Patient with G8 scores ≤ 14/17

排除标准

  • Patients aged less than 65 years
  • Patients who have received or currently in treatment for solid or hematologic cancer
  • Patient with G8 scores more than 14/17

结局指标

主要结局

Number of patients received planned treatment and CGA evaluated with improvement of good quality of life (QOL)

时间窗: 12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months)

To assess the impact of the inclusion of the CGA on the quality of life (QOL) of the elderly onco-hematology patient that result frail in the geriatric screening (G8), compared to the clinical practice that does not include the CGA

次要结局

  • Failure Free Survival (FFS)(From randomisation (December 2019-December 2022))
  • Number of patients received radiotherapy planned and CGA evaluated with improvement of good quality of life (QOL)(12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months))
  • Progression free survival (PFS)(From randomisation (December 2019-December 2022))
  • Occurrence of dose reductions(From randomisation through study completion, an average of 1 year)
  • Overall Survival (OS)(From randomisation (December 2019-December 2022))

研究者

发起方
Lorenza Scotti
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lorenza Scotti

Statistician

University of Eastern Piedmont

研究点 (1)

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